For treatment-naïve adults with HIV-1. See Full Indication.
RESISTANCE RESULTS FOR DOVATO
- As a prespecified secondary endpoint, patients who met the protocol-defined confirmed virologic withdrawal criteria across the pooled GEMINI-1 and GEMINI-2 trials were tested for emergent INSTI or NRTI substitutions conferring resistance through 96 weeks.
Zero Resistance Through 96 Weeks
0Cases of Resistance-Associated Substitutions in GEMINI 1 & 2 (48-Week Pooled Data)
High Barrier to Resistance Supported By 96-Week Data
- No patients receiving the components of DOVATO with confirmed virologic withdrawal across the pooled GEMINI 1 & 2 trials had treatment-emergent INSTI or NRTI resistance substitutions through 96 weeks1,2*
*No patients in either arm receiving DTG-containing regimens had a detectable decrease in susceptibility conferring resistance to the ARVs studied in the pooled resistance analysis data set (n=11 for DOVATO and n=7 for DTG + TDF/TAF with confirmed virologic withdrawal). The population was defined as either virologic nonresponse (a decrease in plasma HIV-1 RNA <1 log10 copies/mL by Week 12, with subsequent confirmation, unless plasma HIV-1 RNA is <200 copies/mL or confirmed plasma HIV-1 RNA levels ≥200 copies/mL on or after Week 24) or virologic rebound (confirmed rebound in plasma HIV-1 RNA levels ≥200 copies/mL after prior confirmed suppression to <200 copies/mL).1,2
ARVs=antiretrovirals; DTG=dolutegravir; FTC=emtricitabine; INSTI=integrase strand transfer inhibitor; NRTI=nucleoside reverse transcriptase inhibitor; TDF=tenofovir disoproxil fumarate.
- Cahn P, Madero JS, Arribas JR, et al. Durable Efficacy of Dolutegravir (DTG) Plus Lamivudine (3TC) in Antiretroviral Treatment–Naive Adults With HIV-1 Infection: 96-Week Results From the GEMINI Studies. Presented at the 10th International AIDS Society (IAS) Conference on HIV Science; July 21-24, 2019; Mexico City, Mexico. Slides WEAB0404LB.
- Data on file, ViiV healthcare group of companies. Research Triangle Park, NC.